Director, Regulatory Operations, Submissions

The Opportunity:

• Lead and be accountable for global regulatory submission execution across all application types, supporting increasing submission volume, portfolio expansion, and organizational growth.

• Provide strategic and operational leadership within Regulatory Operations, contributing to functional direction, capability planning, and continuous improvement while maintaining strong executional accountability.

• Translate regulatory strategies into executable submission plans, timelines, resource requirements, and operational approaches.

• Provide oversight for the planning, preparation, publishing, submission, and archiving of high-quality, compliant global regulatory dossiers.

• Lead, mentor, and develop a submissions-focused team, fostering accountability, collaboration, operational excellence, and continuous improvement.

• Oversee external publishing vendors to ensure timely, compliant, high-quality execution and effective use of external resources.

• Define, own, and maintain submission-related standard operating procedures (SOPs), work instructions, job aids, standards, policies, and best practices to drive consistent execution across programs and regions.

• Drive continuous improvement of submission processes to reduce cycle times, increase predictability, improve quality, and support organizational scale.

• Ensure submission processes and practices align with Quality systems, regulatory requirements, and inspection-readiness expectations.

• Partner closely with Regulatory Affairs, Medical Writing, Quality, Clinical Operations, and other cross-functional stakeholders to establish clear roles, effective handoffs, and coordinated execution across the submission lifecycle.

• Provide operational guidance and training to cross-functional contributors involved in regulatory submissions.

• Communicate complex submission issues and risks clearly and proactively, developing practical solutions that balance compliance, business needs, and the demands of a growing portfolio.

• Advance cross-functional initiatives that improve Regulatory effectiveness and support broader departmental objectives.

• Partner with the Regulatory Systems lead to define business requirements, provide operational input, and ensure regulatory systems and processes effectively support submission execution.

Required Skills, Experience and Education:

• Bachelor’s degree in a life science, or related field with 12+ years of experience in the biotechnology, pharmaceutical, or medical device industry.

• Seasoned people manager with demonstrated experience leading and developing high-performing teams.

• Proven leadership in developing and executing Regulatory Operations strategies within global biotechnology or biopharmaceutical organizations.

• Deep expertise in global submission planning and execution, electronic Common Technical Document (eCTD) standards, regulatory frameworks, and Health Authority requirements.

• Demonstrated ability to contribute to operational strategy while maintaining strong accountability for submission execution, quality, and process excellence.

• Strong understanding of regulatory systems from a submissions operations, business-process, and end-user perspective.

• Experience leading process improvement initiatives within a regulated, compliance-focused environment.

• Strong project and operational management skills, with the ability to manage multiple priorities and deliver results in a dynamic environment.

• Clear and persuasive communicator with the ability to translate complex operational issues for technical, cross-functional, and senior stakeholders.

• Effective collaborator with demonstrated ability to influence and align cross-functional teams.

• Strategic thinker with a practical problem-solving mindset and ability to balance immediate execution needs with longer-term organizational scalability.

• Proficiency with DocuBridge and Veeva Regulatory Information Management (RIM).

Preferred Skills:

• Hands-on regulatory publishing experience with the technical capability to provide publishing support when needed.

• Experience using Smartsheet for submission planning, project tracking, and collaboration.

• Eperience supporting or managing a global regulatory portfolio.

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